Human Genome Sciences Gains FDA Recommendation for Benlysta. Shares Soar 10% in Afterhours Trading

Good news today for Human Genome Sciences and those who suffer from Lupus.  FDA voted in favor of Benlysta with a strong vote of 13-2.  Although the FDA doesn't always approve drugs that are recommended by the panel, many times they do, and more so with an Approval Recommendation than without one.  Shares of Human Genome Sciences were up 10.51% to 28.60 in afterhours trading. 

Trading was halted throughout the day and will resume normal trading tomorrow.  I expect a strong day tomorrow and it should be watched closely tomorrow.  It's partner Glaxo SmithKline was trading slightly higher at 39.45 +0.91 a 2.36% gain.  This is really good news for investors who have watched HGSI drop from a high of  30.18 in September to a low of 23.60 this past Friday from a Doctor scandal, a CRL for Zalbin, and safety concerns from their Phase III clinical trial results for Benlysta. 

It did report positive 3Q 2010 results in the following press release,  Human Genome Sciences Announces Third Quarter 2010 Financial Results and Key Developments.  I see HGSI stock to rise towards the 32-35 mark with possible Full Approval coming December 9th.  

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FDA panel favors lupus drug from Human Genome Sciences despite mixed results in studies

Tuesday's FDA Panel Review for Human Genome Science's Benlysta

Purple Walk for Lupus Awareness

Everything you need to know about Tuesday's FDA panel recommendation for Human Genome Sciences therapy for Lupus, Benlysta.  If approved Benlysta would be the first approved therapy in 50 years for Lupus.  Friday the FDA released the notes for the upcoming panel review Tuesday, November 16th.  Concerns for the panel Tuesday were an increased risk of suicide, risk of infection, and decreased efficacy in African-American patients, who are more prone to Lupus.  Forbes' The Medicine Show Blog with Matthew Herper highlighted some of these concerns.  Benlysta is teamed up with Glaxo SmithKline and if approved Human Genome Sciences will share marketing costs and profits.  The expected market is anywhere between 1-3 Billion.

I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA.  With that being said though, the FDA has rejected a lot of drugs this year and is very conservative.  There are some concerns and more clinical trials could be advised before approval.  We will have to see.  Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus.  The concerns dropped the stock and has investors spooked, but I still think that it will be recommended.  I hope I am not wrong on this one. 

For more information about Human Genome Sciences visit their website HGSI.com. 

Learn more about Lupus (SLE), please visit their website at Lupus.org.

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For more on Tuesday's Decision

New Targets, Dual Agonists Increase Possibilities for Treating Diabetes

Image via Wikipedia Fritz French, Chief Executive Officer, Marcadia Biotech, Carmel, Ind.
Drug Discovery & Development - August 16, 2010

Diabetes is a common chronic disease affecting an estimated 285 million adults worldwide. This number will continue to grow as the population ages and becomes more obese—both risk factors for type 2 diabetes. The diabetes treatment market generated over $25 billion in 2009 and the number of patients is continuously rising.

Chasing Influenza: History of the Flu

Image via Wikipedia Here is a really informative article on the History of the Flu by Quintiles White Papers. PDF format is the link below. It's Flu season again. Companies are ramping up their stockpiles of Flu Vaccines and you can get the flu shot at Walgreens and CVS these days.

I personally don't believe all the hype and practice safe "People handling" when I go out and use hand sanitizers every chance I get. One day a real Pandemic will emerge like the 1918 Flu and there is not much we can do about it. Novartis, Glaxo SmithKline, Baxter, and MedImmune are your top Flu stocks.

Chasing Influenza

Last Week's Top Performers for the BioPharma Market

I was almost too distaught to write an article after last Friday but decided we have to move on and look for gems in the rough. So there were a few Gems but a lot of Glooms. BioPharma Indexes are down almost 5 percent based on last weeks momentum downslide in the overall market. For just a taste of how bad it was ProShares UltraShort S&;P500 (ETF) (NYSE:SDS) was up 7.4% on shorting the market.

But lets take a look at some Top Performances last week.

Biovail, Valeant Pharmaceuticals, GSK gain FDA recommendation for Epilepsy drug Potiga

Image via Wikipedia

Today saw some good news from the FDA as they recommended the joint venture drug, Potiga, by Valeant Pharmaceuticals and Glaxo SmithKline. Valeant is in merger acquisitions with Biovail that should be completed by the year's end.

U.S. Food and Drug Administration advisory committee voted unanimously 11-0 that clinical studies had provided substantial evidence on the safety and effectiveness of ezogabine to treat epilepsy. The Prescription Drug User Fee Act goal date for the FDA to complete its review of the drug’s application is August 30. The drug will be aimed at patients whose other epilepsy medications failed.

Market Rumors Human Genome Sciences as a takeover target

Rumors of Glaxo's takeover of Human Genome Sciences for $30/share have pushed the stock up considerably today. Human Genome Sciences stock (HGSI) was up $2.03 to $19.21 per share in afternoon trading with a gain of 11.79%. Aftermarket trading is up +0.46 to 19.66, another gain of 2.40%. I see this as only a rumor but it does make some since as Human Genome and Glaxo have been partner's since 1993. Human Genome Sciences worked together and received royalties from Glaxo in 2006 for the Diabetes medication Syncria. April 2008 saw HGSI reacquiring the rights for the HGS-ETR1 and HGS-ETR2 oncology programs from Glaxo.

So what is going on here? Has Glaxo seen results from their second set of pivotal Phase III trial and are ready to make a deal? Results are set to be released in November for their Lupus drug BENLYSTA. HGSI press releases from their website can be found here Benlysta Results. For more takeover target information check out the Washington Biz Journal's article HGSI:a takeover target?. MedicalNewsToday posted an article in June announcing the Lupus drug's positive results on Benlysta.

Regardless, I see this as positive financial news for Human Genome Sciences which once traded in March around 0.45. I'm not sure I believe the hype in the rumor but I do like the news coming in and anticipation for results in November. Many analysts see this stock as undervalued and have a target range around 26/share.

Human Genome Sciences has declined to comment on the rumor. Human Genome corporate leaders have stated in the past that they are seeking independence in approval of these 2 trials and have no reason to change that. This was quoted by CEO Tom Watkins in July: “We’re really focused on getting the drugs to patients. We think we have the capability and wherewithal to do it on our own, and we don’t see any reason why that would change.”

With that said I don't know. I've seen CEOs take the money and run but I don't think this is the case. Just a hunch. Rumors have surrounded Spectrum Pharma as a takeover target for Bayer AG recently and those did not fall through either. It is a good marketing tool to push the stocks price up and it works pretty well. Needless to say I like Human Genome's chances with their Phase III results in November. I do see the stock price going higher with positive results and after all is said and done with this rumor I see the price will value out and be a good buy. Just a reminder not to chase stocks. Buy at a valued price and good things will happen.

Disclosure: Long Human Genome Sciences